Clincosm LogoSign in Get a demo

A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03668496
Collaborator
(none)
390
Enrollment
53
Locations
2
Arms
37.7
Anticipated Duration (Months)
7.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive cross over treatment of SHR-1210 monotherapy after confirmed disease progression. Treatment cycles of chemotherapy will be 4-6 which will be decided by investigators.

Study Design

Study Type:
Interventional
Actual Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized,Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of SHR-1210 in Combination With Carboplatin and Paclitaxel Versus Placebo in Combination With Carboplatin and Paclitaxel in First-Line Stage IV Squamous Non-Small Cell Lung Cancer
Actual Study Start Date :
Nov 9, 2018
Actual Primary Completion Date :
Nov 6, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-1210 +chemotherapy

subject will receive SHR-1210 200mg every 3 weeks, carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles

Drug: SHR-1210
Drug delivery cycle is 3 weeks, and in the experimental group,200 mg shr-1210 was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
Active Comparator: chemotherapy

carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles

Drug: The placebo
in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [up to 24 month]

    PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

  1. Progression-free survival [up to 24 month]

    Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1

  2. Overall Survival (OS) [up to 24 month]

    defined as time from the randomized to the time of the patient's death from any reason assessed by researchers.

  3. Objective Response Rate (ORR) [up to 24 month]

    The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.

  4. disease control rate (DCR) [up to 24 month]

    The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.

  5. Duration of response （DoR） [up to 24 month]

    According to Recist v 1.1 accessed by investigators

  6. Adverse events (AEs) [up to 24 month]

    All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) and clinical stage IV

  2. has not received prior systemic treatment for metastatic NSCLC.

  3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status

  4. Has archived Tumor tissue samples

  5. Subject must have a measurable target lesion based on RECIST v1.1 .

  6. Has adequate organ function.

  7. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug.

  8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

  1. active brain metastases and meningeal metastasis

  2. uncontrollable tumor-related pain

  3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;

  4. radiotherapy to lung that is >30 Gy within 24 weeks before the first dose,

  5. imaging (CT or MRI) showed that the tumor invading the large vessels

  6. Known EGFR/ALK mutation.

  7. subjects with any known or suspected autoimmune diseases

  8. subjects with known or suspected interstitial pneumonia;

  9. Subjects with severe cardiovascular and cerebrovascular diseases

  10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;

  11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period;

  12. positive HIV test;

  13. active hepatitis B

  14. evidence of active TB infection within 1 year before first dose;

  15. severe infection occurred within 4 weeks before the first dose

  16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month

  17. subjects who is on systemic immunogenic agents;

  18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;

  19. History of severe allergic reactions to carboplatin or paclitaxel or their preventive drugs;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospital Hefei Anhui China 230036
2 The Second Affiliated Hospital Of Anhui Medical University Hefei Anhui China 230036
3 Anhui Chest Hospital Hefei Anhui China MD
4 Beijing Cancer Hospital Beijing Beijing China 100000
5 The Fifth Medical Center of PLA Ceneral Hospital Beijing Beijing China 100000
6 The Seventh Medical Center of PLA Ceneral Hospital Beijing Beijing China 100000
7 Beijing Cancer Hospital Beijing Beijing China 100142
8 Chongqing University Cancer Hospital Chongqing Chongqing China 400030
9 900TH Hospital of Joint Logistics Support Force Fuzhou Fujian China 350001
10 Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou Guangdong China 510095
11 The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510120
12 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515
13 Jieyang People's Hospital Jieyang Guangdong China 522000
14 Affiliated Hospital of Zunyi Medical University Zunyi Guizhou China 563003
15 Affiliated Hospital of Chengde Medical College Chengde Hebei China 067000
16 The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital) Shijiazhuang Hebei China 50000
17 Tangshan People's Hospital Tangshan Hebei China 63001
18 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150000
19 Henan Cancer Hospital Zhengzhou Henan China 450000
20 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450000
21 Henan Provincial People's Hospital Zhengzhou Henan China 450003
22 Hubei Cancer Hospital Wuhan Hubei China 430000
23 Tongji Hospital, Tongji Medical College of Hust Wuhan Hubei China 430000
24 Xiang yang Central Hospital Xiangyang Hubei China 441000
25 Hunan Cancer Hospital Changsha Hunan China 410006
26 The Second Xiangya Hospital Of Central South University Changsha Hunan China 410008
27 The Third Xiangya Hospital Of Central South University Changsha Hunan China 410013
28 Jiangsu Province Hospital Nanjing Jiangsu China 210000
29 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008
30 Affiliated Hospital of Jiangnan University Wuxi Jiangsu China 214122
31 Northern Jiangsu People's Hospital Yangzhou Jiangsu China 225001
32 Jiangxi Cancer Hospital Nanchang Jiangxi China 330006
33 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
34 China-Japan Union Hospital of Jilin University Changchun Jilin China 130012
35 Jilin Cancer Hospital Changchun Jilin China 130012
36 The First Bethune Hospital of Jilin University Changchun Jilin China 130012
37 The First Hospital of China Medical University Shenyang Liaoning China 110001
38 Jinan Central Hospital Jinan Shandong China 250013
39 LinYi Cancer Hospital Linyi Shandong China 276001
40 Shanghai Changhai Hospital Shanghai Shanghai China 200433
41 Shanghai Pulmonary Hospital, Tongji University Shanghai Shanghai China 200433
42 Baoji Central Hospital Baoji Shanxi China 721000
43 Heping Hospital Affiliated to Changzhi Medical College Changzhi Shanxi China 046000
44 Shanxi Provincial People's Hospital Taiyuan Shanxi China 030000
45 Shaanxi Provincial Cancer Hospital Xian Shanxi China 710061
46 Sichuan Provincial Cancer Hospital Chengdu Sichuan China 610000
47 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060
48 Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Kunming Yunnan China 650118
49 The First Affiliated Hospital，ZheJiang University Hangzhou Zhejiang China 310003
50 Sir Run Run Shaw Hospital ZheJiang University School Of Medicine Hangzhou Zhejiang China 310018
51 ZheJiang Cancer Hospital HangZhou Zhejiang China 310022
52 The Second Affiliated Hospital of Zhejiang University of Medicine Hangzhou Zhejiang China 310052
53 Taizhou Hospital of Zhejiang Province Taizhou Zhejiang China 317000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Study Director: Jianjun Zou, MD, PhD, Jiangsu HengRui Medicine Co., Ltd.
  • Principal Investigator: Caicun Zhou, MD, PhD, Tongji University, Shanghai Pulmonary Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03668496
Other Study ID Numbers:
  • SHR-1210-III-307
First Posted:
Sep 12, 2018
Last Update Posted:
Mar 15, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Mar 15, 2021